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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameanti-hcv assay
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP010021
Supplement NumberS003
Date Received07/16/2004
Decision Date07/30/2004
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing equipment and manufacturing process steps acceptance criteria associated with this equipment change. The proposed changes affect the manufacturing of vitros immunodiagnostic products anti-hcv reagent pack.
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